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NCT Number: NCT04691817

Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy

This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.

Recruiting

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Key information

Conditions

Lung Cancer, Nonsmall Cell Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Mel V, BA

CONTACT

[email protected]

215-220-9703

Melina Marmarelis, MD, MSCE

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
  • Prior exposure to at least 1 line of therapy
  • Exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial
  • ECOG PS 0-2

Exclusion criteria

  • Presence of a driver mutation that is susceptible to targeted therapy
  • No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
  • Other active invasive malignancy requiring ongoing therapy
  • Evidence of progressing or untreated brain metastases
  • Evidence or history of leptomeningeal disease
  • Uncontrolled tumor related pain
  • History of an autoimmune disease or IPF

Treatment and study plan

Atezolizumab

Drug

1200mg infusion

Other names: Tecentriq

Tocilizumab

Drug

Tocilizumab 6mg/kg or 4mg/kg infusion

Other names: Actemra, RoActemra, RO4877533

Primary outcomes

  1. Overall response rate (ORR)

    Time frame: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.

    Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure.

    Estimate the time from first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure

  2. Dose Limiting Toxicities of the combination

    Time frame: From first dose of protocol treatment until 49 days post treatment

    Determine dose limiting toxicities of the combination

  3. Progression free survival (PFS).

    Time frame: From 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months.

    Estimate the time from first dose of protocol treatment until first radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if there is no progression date registered.

Other outcomes

  1. Clinical outcomes

    Time frame: From enrollment until dealth due to any cause or last patient contact alive until 3 months after study closure

    Correlate clinical outcomes with potential markers of immune escape and changes in the tumor microenvironment and blood using a novel field theory based methods under development by Cold Spring Harbor Laboratory.

Study contacts

Contact information is provided by the study sponsor or research team.

Melina Marmarelis, MD, MSCE

CONTACT

[email protected]

215-615-5835

Melissa Volpe, BA

CONTACT

[email protected]

215-220-9703

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2020
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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